(271 days)
The IDSS-ForceTriad Control Module is designed for integration in the IDSS(Integrated Digital Surgical Suite) and enables the Covidien ForceTriad Energy Platform to be controlled remotely.
The IDSS ForceTriad Control Module is an additional function to the IDSS, which is an integrated operating room system controlling video displays, observation cameras, audio video equipment, teleconferencing and the routing of video and images from multiple sources to multiple destinations via a touch screen interface. With the IDSS ForceTriad Control Module, operation room staff is able to control the ForceTriad setup from the touch panel location rather than using the ForceTriad unit itself.
The provided FDA 510(k) summary (K153205) describes the IDSS-ForceTriad Control Module. This device is an accessory that enables remote control of the Covidien ForceTriad Energy Platform within an Integrated Digital Surgical Suite (IDSS). The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to showcase the performance of an AI/ML algorithm that interprets medical images or data.
Therefore, many of the requested criteria regarding AI/ML performance studies, such as effect size of human readers with AI assistance, standalone algorithm performance, number of experts for ground truth, and training set information, are not applicable to this document.
Here's an analysis of the provided information, focusing on the context of a medical device accessory and its validation:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software Verification and Validation of interfaces, features, and non-functional reliability. | Software Verification and Validation testing were performed on interfaces, feature functional requirements, and non-functional reliability. |
| Risk analysis in accordance with established in-house acceptance criteria based on ISO 14971:2007. | The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. |
| Device meets the needs of users and does not raise new safety and efficacy issues compared to the predicate device. | Testing and evaluation indicate that the system meets the needs of the users of the device and does not raise any new safety and efficacy of the predicate device. The IDSS –ForceTriad Control Module is substantially equivalent to the predicate device since intended use, operational principle, basic technology and design are similar. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is a control module, not a diagnostic or AI image analysis system that would typically use a "test set" of medical images or patient data. The testing is focused on software functionality and risk management.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As noted above, this is a control module, not an AI/ML system requiring expert-adjudicated ground truth for medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML system requiring adjudication of medical cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This filing concerns a control module for an energy platform, not an AI-assisted diagnostic or imaging device. There is no mention of human readers or AI assistance in the context of clinical interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its function is to remotely control an existing medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the software validation and risk analysis, the "ground truth" would be related to the correct and expected functionality of the software according to its design specifications, user requirements, and safety standards (e.g., ISO 14971:2007). This is established through internal design documents, functional specifications, and compliance with regulatory standards, rather than clinical outcomes or expert consensus on medical findings.
8. The sample size for the training set
Not applicable. This is not an AI device that involves a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.